Evaluation of IVA (SE Femur Scans) to Identify Incomplete AFFs (NCT01747304) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation of IVA (SE Femur Scans) to Identify Incomplete AFFs
Canada285 participantsStarted 2012-07
Plain-language summary
DXA scanners are routinely used to assess bone mineral density (BMD) and fracture risk in osteoporosis patients. They provide detailed bone imaging in a low radiation setting. Hologic manufactures scanners that are able to perform high definition instant vertebral fracture assessment (HD-IVA) used to screen at-risk patients for asymptomatic spine fractures instantly and reliably at the same time they are having their yearly BMD. We wish to investigate whether this same proven technology (HD-IVA scan mode) used on femurs (the scan mode is now called SE Femur scans) can be used to screen for atypical fractures of the femur in patients at risk for these debilitating fractures. In this proof of concept study, we propose to examine whether DXA scanners can provide a sensitive low radiation screening method to identify incomplete AFFs in patients with known incomplete AFFs and in patients at risk.
Who can participate
Age range
18 Years – 100 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. A subject must have experienced an incomplete atypical low trauma fracture of the femoral shaft;
. Is a patient at the UHN osteoporosis clinic.
. Must be scheduled for a bone mineral density scan at UHN
. Have been on any bisphosphonate for 5 years or longer, and;
. Have unexplained symptoms of leg, hip, thigh, or knee pain.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
HD-IVA visualization of incomplete femur fractures